Clinical Outcome Assessments in Clinical Research

Catalog description

Clinical outcome assessments (COAs) are measures used in clinical trials designed to evaluate how a new intervention affects how patients feel or function. There are four types of COAs: patient-reported (e.g., self-reported pain), observer-reported (e.g., parent report of child's physical functioning), clinician-reported (e.g., clinician rating of disease severity), and performance outcome measures (standardized tasks performed in a standardized environment, such as 6-minute walk test). In this course, we will learn how to (a) develop a conceptual model of the health outcomes that are important to measure; (b) select the most appropriate type of COA for measuring a given health outcome; (c) find and evaluate existing COAs or develop a new COA; and (d) use scores from a COA to construct a meaningful trial endpoint. The course will include general discussions of qualitative and quantitative methods in developing and evaluating measures. The emphasis throughout the course will be on preparing future study Principal Investigators to use COAs effectively rather than on becoming expert at specific technical skills (e.g., advanced psychometric analyses). Prerequisite: None. Credits: 2.